Definitive Radiation Therapy for Inoperable Breast Cancer

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer; Breast Adenocarcinoma

• Registration Number: NCT07122713
• Lead Sponsor: Alexander Stessin

Brief Summary

The purpose of this study is to find out if adding radiation therapy to routine medications for breast cancer helps in reducing and preventing the cancer from getting worse. Patients with a locally advanced breast cancer who cannot, or do not want to, undergo surgery are eligible to participate. Participation in this study does not prevent you from undergoing surgery in the future.

Detailed Description

Patients who cannot undergo surgical resection for either breast cancer or local control of metastatic cancer have limited effective treatment options. Treatments typically employed in the adjuvant setting have been found in the definitive setting to be inferior to surgery followed by adjuvant therapy. This raises the necessity of evaluating the use of ablative doses of radiation to provide durable local control of the tumor in such patients. Indeed, there is growing evidence that RT is effective in the adjuvant setting. This is a study of concurrent ultra-hypofractionated whole breast whole breast radiation delivered via simultaneous integrated boost to the gross tumor for breast cancer patients not undergoing surgery.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Study Start: 2025-09-30
• Primary Completion: 2028-09-30
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Biopsy proven invasive carcinoma of the breast, either lobular, ductal and/or no special type
• T1-T4, N0-2, M0-1 invasive breast carcinoma by radiological or clinical criteria
• Cancer is deemed unresectable, or the patient is a poor surgical candidate as determined following evaluation by a surgeon, or patient declines surgery.
• Life expectancy > 6 months
• Negative pregnancy test at the time of start of treatment in any female of reproductive age

Exclusion Criteria

• Concurrent systemic therapy (except for endocrine therapy, HER2-targeted therapy, or immunotherapy which are permitted)
• Prior radiation to ipsilateral breast or regional nodes
• Inability to receive study treatment planning and treatment secondary to body habitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment Safety	12 months	Incidence of physician-assessed treatment-related toxicity ≥ Grade 4 events, as defined using CTCAE 5.0

Secondary Outcome Measures

Name	Time	Method
Acute Toxicity	12 months	Percent of participants with any physician-assessed treatment-related Grade 1-5 events using CTCAE 5.0. Grade 1 events are limited to fatigue, skin, breast, ribs, heart and lungs.
Late Toxicity	5 years	Percent of participants with any physician-assessed treatment-related Grade 2-5 events using CTCAE 5.0.
Treatment Tolerability by EORTC QLQ-C30	2 years	Patient reported quality of life measured using the quality of life questionnaire C30 (QLQ-C30), developed by the European Organisation for Research and Treatment of Cancer. This scale includes 5 functional and 3 symptom scales, each scored as a 0-100 scale, where higher scores indicate a better outcome on functional scales and global health status, and a worse outcome on symptoms.
Treatment Tolerability by EORTC QLQ-BR42	2 years	Patient reported quality of life measured using the quality of life questionnaire BR42 (QLQ-BR42), developed by the European Organisation for Research and Treatment of Cancer. This scale assesses symptoms, body image and sexual functioning scales, each scored as a 0-100 scale, where higher scores indicate worse outcome on symptoms.
Tumor Response Rate in the Gross Disease Volume (40Gy)	1 year	Measured on follow-up MRI or CT imaging using RECIST criteria
Progression Free Rate in the Microscopic Disease Volume (26Gy)	1 year	Measured on follow-up MRI or CT imaging using RECIST criteria
Clinical Response in patients with Palpable Disease	1 year	Caliper measurements (2-dimensional)

Trial Locations

Locations (1)

Stony Brook University Cancer Center; 🇺🇸 Stony Brook, New York, United States